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Clinical Trials/NCT01745536
NCT01745536WithdrawnNot Applicable

"Impact of a Closed System in Donor Oocyte Vitrification"

Instituto Valenciano de Infertilidad, IVI VALENCIA4 sites in 1 countryStarted: November 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
4
Primary Endpoint
Survival after oocyte vitrification using the closed device Cryotop®

Study Overview

Brief Summary

This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.

Detailed Description

The Cryotop method for oocyte vitrification is classified as "open system", which means that it requires direct contact with liquid nitrogen during the vitrification process. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed. Instead closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. Open systems have proven highly effective in achieving similar outcomes with vitrified oocytes compared to those achieved with fresh ones. On the contrary, closed systems have failed to be as effective as open ones when used for oocyte vitrification. Although open systems have proven to be highly efficient, where many other methods have failed, they have been related to a theoretical risk of contamination due to direct contact with liquid nitrogen. Though to date there have been no reported cases of transmission of disease after cryo-transfers either for slow freezing or vitrification, some European countries prohibit the use of open systems for vitrification. In this study, we will evaluate the results after the donor oocyte vitrification, using a modification of a current device (Cryotop®), which makes it capable of being hermetically sealed. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using the closed device versus oocytes vitrified using the traditional open device.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • < 35 years old
  • Normal physical and gynecological examinations
  • No family history of hereditary or chromosomal diseases.
  • Normal karyotype
  • Negative screening for sexually transmitted diseases.
  • Oocyte recipients:
  • Oocyte recipients < 50 years old
  • Body mass index < 30
  • < 2 previous IVF failures
  • No severe male factor
  • No recurrent miscarriage
  • No hidrosalpinx
  • No adenomyosis
  • No AMH alterations

Exclusion Criteria

  • Donors and recipients not meeting inclusion criteria

Outcomes

Primary Outcomes

Survival after oocyte vitrification using the closed device Cryotop®

Time Frame: >2 hours

Survival will be evaluated morphologically two hours after warming.

Secondary Outcomes

  • Embryo development(From thawing and until pregnancy outcome (0-9 months))

Investigators

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ana Cobo

Cryo-biology Unit director at IVI Valencia, Spain

Instituto Valenciano de Infertilidad, IVI VALENCIA

Study Sites (4)

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